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Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter (SAFE-DCB)

Primary Purpose

Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTA (Lutonix® 035 DCB Catheter)
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
  2. The subject agrees to comply with the protocol-mandated follow-up procedures and visits.
  3. The subject is ≥ 21 years old.
  4. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU.

Exclusion Criteria:

  1. The subject is unable or unwilling to provide informed consent.
  2. The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits.
  3. The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry procedures and follow-up.

Sites / Locations

  • Lake Martin Laser and Vein Institute
  • Chandler Regional Medical Center
  • St. Luke's Hospital- Phoenix
  • UCSD Health System
  • Colorado Heart and Vascular
  • Hartford Hospital
  • MedStar Health Research Institute
  • Research Physicians Network Alliance
  • Bradenton Cardiology Center
  • Clearwater Cardiovascular & Interventional Consultants
  • Jacksonville Center for Clinical Research
  • Sarah Cannon Research Institute, LLC
  • Florida Hospital
  • Orlando Health
  • Emory University
  • Northside Hospital, Inc
  • Vascular Interventional of Thomasville, Associates
  • Kaiser Foundation Hospitals
  • Peoria Radiology & Research Foundation
  • Prairie Education and Research Cooperative
  • Franciscan St. Francis Health
  • Midwest Cardiovascular Research Foundation
  • University of Iowa Hospitals and Clinics
  • Hutchinson Regional Medical Center - Hutchinson, Inc
  • Maine Medical Center
  • MedStar Health Research Institute
  • Cape Cod Research Institute
  • Henry Ford Health System
  • St. John Hospital and Medical Center
  • Sparrow Clinical Research Institute
  • DLP Marquette General Hospital
  • Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital
  • Munson Medical Center
  • Merit Health Wesley
  • Freeman Health System
  • Hackensack University Medical Center
  • Cardiovascular Associates of Delaware Valley
  • Jersey Shore University Medical Center
  • New York Hospital-Queens
  • Mount Sinai Beth Israel
  • The Feinstein Institute for Medical Research
  • The Research Foundation for Suny
  • CaroMont Heart Clinical Research
  • LeBauer Cardiovascular Research Foundation
  • Carolina East Health System
  • Rex Hospital, Inc
  • Mercy West Hospital
  • Jobst Vascular Institute
  • Jane Phillips Memorial Medical Center
  • University of Oklahoma Health Science Center
  • Integris Baptist Medical Center, Inc
  • Providence Health & Service
  • Lankenau Institute for Medical Research
  • Saint Vincent Consultants in Cardiovascular Diseases
  • Heart Institute at Largo
  • Allegheny-Singer Research Institute
  • Pinnacle Health Cardiovascular Institute
  • The Miriam Hospital - A Lifespan Partner
  • Vascular Access Solutions
  • Stern Cardiovascular Foundation, Inc
  • Stern Cardiovascular Foundation Inc.
  • Seton Heart Institute
  • Cardiovascular Specialists of Texas
  • Methodist Health System Clinical Research Institute
  • El Paso Cardiology Associates, P.A.
  • Houston Methodist Research Institute
  • Virginia Cardiovascular Specialists
  • Sentara Medical Group
  • Lake Washington Vascular, PLLC
  • CAMC Health Education and Research Institute
  • Bellin Memorial Hospital, Inc
  • Wisconsin Heart-Meriter
  • Columbia St. Mary's, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTA (Lutonix® 035 DCB Catheter)

Arm Description

Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.

Outcomes

Primary Outcome Measures

Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure.
Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization.

Secondary Outcome Measures

Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates).
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates).
Percentage of Participants With Acute Device and Procedural Success
Lesion success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Percentage of Participants With Primary Patency at 12 Months Post Index Procedure
The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first.
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates).
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
Freedom from major amputation of the target limb defined as above the ankle amputation

Full Information

First Posted
April 20, 2015
Last Updated
May 12, 2020
Sponsor
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT02424383
Brief Title
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
Acronym
SAFE-DCB
Official Title
A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2015 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
Detailed Description
The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Peripheral Vascular Diseases, Arterial Occlusive Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1005 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTA (Lutonix® 035 DCB Catheter)
Arm Type
Experimental
Arm Description
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
Intervention Type
Device
Intervention Name(s)
PTA (Lutonix® 035 DCB Catheter)
Intervention Description
Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough. The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
Primary Outcome Measure Information:
Title
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
Description
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure.
Time Frame
12 months post-index procedure
Title
Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure
Description
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization.
Time Frame
30 days post index procedure
Secondary Outcome Measure Information:
Title
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
Description
TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates).
Time Frame
6 , 12, 24, and 36 months
Title
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.
Description
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates).
Time Frame
6, 24, and 36 months post index procedure
Title
Percentage of Participants With Acute Device and Procedural Success
Description
Lesion success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Time Frame
At time of Index Procedure
Title
Percentage of Participants With Primary Patency at 12 Months Post Index Procedure
Description
The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first.
Time Frame
12 months post-index procedure
Title
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
Description
Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates).
Time Frame
6, 12, 24, and 36 Months Post Index Procedure
Title
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
Description
Freedom from major amputation of the target limb defined as above the ankle amputation
Time Frame
6, 12, 24, and 36 Months Post Index Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site. The subject agrees to comply with the protocol-mandated follow-up procedures and visits. The subject is ≥ 21 years old. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU. Exclusion Criteria: The subject is unable or unwilling to provide informed consent. The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits. The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry procedures and follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Shammas, MD
Organizational Affiliation
Midwest Cardiovascular Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Woo, MD
Organizational Affiliation
MedStar Regional
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lake Martin Laser and Vein Institute
City
Alexander City
State/Province
Alabama
ZIP/Postal Code
35010
Country
United States
Facility Name
Chandler Regional Medical Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
St. Luke's Hospital- Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
UCSD Health System
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Colorado Heart and Vascular
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Research Physicians Network Alliance
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Bradenton Cardiology Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Clearwater Cardiovascular & Interventional Consultants
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Sarah Cannon Research Institute, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital, Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Vascular Interventional of Thomasville, Associates
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Kaiser Foundation Hospitals
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Peoria Radiology & Research Foundation
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Franciscan St. Francis Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Hutchinson Regional Medical Center - Hutchinson, Inc
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
MedStar Health Research Institute
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Cape Cod Research Institute
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
DLP Marquette General Hospital
City
Marquette
State/Province
Michigan
ZIP/Postal Code
49855
Country
United States
Facility Name
Cardiac & Vascular Research Center of Northern Michigan/McLaren Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Merit Health Wesley
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cardiovascular Associates of Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
New York Hospital-Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
The Feinstein Institute for Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
The Research Foundation for Suny
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CaroMont Heart Clinical Research
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
LeBauer Cardiovascular Research Foundation
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Carolina East Health System
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Rex Hospital, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Mercy West Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Facility Name
Jobst Vascular Institute
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43603
Country
United States
Facility Name
Jane Phillips Memorial Medical Center
City
Bartlesville
State/Province
Oklahoma
ZIP/Postal Code
74006
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Integris Baptist Medical Center, Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Providence Health & Service
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lankenau Institute for Medical Research
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Saint Vincent Consultants in Cardiovascular Diseases
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16502
Country
United States
Facility Name
Heart Institute at Largo
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Allegheny-Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
The Miriam Hospital - A Lifespan Partner
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vascular Access Solutions
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Stern Cardiovascular Foundation, Inc
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Stern Cardiovascular Foundation Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Seton Heart Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Cardiovascular Specialists of Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Methodist Health System Clinical Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
El Paso Cardiology Associates, P.A.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Cardiovascular Specialists
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Sentara Medical Group
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23542
Country
United States
Facility Name
Lake Washington Vascular, PLLC
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
CAMC Health Education and Research Institute
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Bellin Memorial Hospital, Inc
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Wisconsin Heart-Meriter
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States
Facility Name
Columbia St. Mary's, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter

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